Implantable Ultrafiltration System with Closed-Loop Fluid Control

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Solution Overview

Problem

Current ultrafiltration therapies for heart failure and renal dysfunction lack automated control mechanisms, making it difficult to determine the optimal rate and volume of fluid removal, leading to potential overdiuresis, inadequate symptom relief, and additional kidney strain.

Innovation Solution

An implantable medical device system that includes physiological sensors to monitor fluid status and an ultrafiltration unit, enabling automated or semi-automated control of ultrafiltration therapy by adjusting fluid removal rates based on real-time fluid status measurements, such as transthoracic impedance and pressure signals, to maintain optimal fluid balance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual control of ultrafiltration is used, then the system is simple to operate, but the precision of fluid removal control is insufficient leading to potential overdiuresis or inadequate symptom relief

Engineering Contradiction:

Improvefluid status monitoring precisionVSAvoidsystem complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent implements a closed-loop feedback system where physiological sensors continuously monitor fluid status parameters (transthoracic impedance, pressure signals) and automatically adjust ultrafiltration rates. The controller receives real-time feedback from sensors and modulates the ultrafiltration pump accordingly, enabling precise fluid removal control without manual intervention and preventing both overdiuresis and inadequate symptom relief.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The ultrafiltration system performs self-regulation through automated control algorithms that process sensor data and adjust treatment parameters without requiring continuous manual input from healthcare providers. The system independently determines optimal fluid removal rates based on real-time physiological measurements, reducing operational complexity while maintaining high precision control.

Inventive Principle:

Principle #25Self-service

2Productivity

If fluid removal rate is increased to provide faster symptom relief, then productivity improves, but harmful effects occur through overdiuresis and kidney strain

Engineering Contradiction:

Improvefluid removal efficiencyVSAvoidoverdiuresis and kidney strain

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors physiological parameters including transthoracic impedance and pressure signals to detect early signs of overdiuresis or kidney stress. When abnormal patterns are detected, the controller automatically reduces the ultrafiltration rate or terminates treatment, preventing harmful effects while maintaining high productivity during appropriate treatment phases.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent incorporates safety thresholds and alarm systems that activate before harmful effects occur. The controller is programmed with predetermined limits for fluid removal rates and cumulative volumes, and physiological parameters that indicate impending kidney strain or overdiuresis. These preemptive measures cushion against harmful effects by preventing the system from reaching dangerous operating conditions.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If fluid removal is delayed to avoid overdiuresis, then harmful effects are reduced, but symptom relief duration is insufficient

Engineering Contradiction:

Improvesafety of fluid removalVSAvoidduration of symptom relief

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent implements continuous or near-continuous ultrafiltration therapy with automated monitoring and adjustment, eliminating gaps in treatment. The system maintains therapeutic fluid removal throughout the treatment period while continuously adapting rates to physiological conditions, ensuring sustained symptom relief without requiring interruption for safety concerns. This continuous action approach extends the duration of beneficial effects while maintaining safety through real-time feedback control.

Inventive Principle:

Principle #20Continuity of useful action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This system allows for precise regulation of ultrafiltration therapy, improving patient outcomes by preventing overdiuresis, ensuring sustained symptom relief, and reducing the burden on compromised kidneys, while minimizing hospitalization risks.

Implementation Method 1

fluid status measurements derived from physiological sensor signals, such as impedance or pressure signals

Methodology Applied

Scientific EffectImpedance measurement: Electrical Impedance Tomography

Implementation Method 2

Ultrafiltration involves filtering a patient's blood to remove excess fluid then returning the filtered blood back to the patient

Methodology Applied

Scientific EffectUltrafiltration: Filter (physical)

Data Source

PatentUS9943633B2System and method to regulate ultrafiltration

Publication Date: 2018.04.17 MOZARC MEDICAL US LLC

AI summary

A medical device system including a physiological sensor and ultrafiltration unit senses a physiological signal in a patient and computes a fluid status measurement of the patient using the physiological signal. Ultrafiltration therapy is delivered to the patient according to a therapy delivery control parameter established in response to the fluid status measurement.